Same-day provision of results from a point-of-care viral
load test – rather than waiting weeks for laboratory results to be collected –
resulted in a 14% improvement in virological suppression and retention in care
in a public clinic in South Africa. This is the first randomised controlled
trial to test the impact of rapid, point-of-care viral load testing and was
presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2019)
in Seattle today.

Dr Paul Drain of the University of Washington said that
delays in obtaining laboratory test results in resource-limited settings
present challenges for monitoring HIV treatment. Individuals with sub-optimal
results need to be recalled for another clinic appointment, but the patients
who find adherence challenging are sometimes also the patients who do not
immediately respond to such requests.

If viral load results are available while the patient is
still in the clinic, any problems can be quickly identified and supportive
interventions can be offered immediately.

The study’s hypothesis was that rapid HIV viral load
testing, implemented by nurses, is an effective and cost-efficient strategy for
management of chronic HIV infection in the majority of patients, thereby
allowing more resources to be directed towards the minority of patients who
need greater attention.

This open-label, randomised controlled trial was conducted
in one public clinic in Durban. Patients were recruited to the study six months
after initiating antiretroviral therapy (ART) – the clinic visit when viral load is
measured for the first time.

In the intervention arm, patients received point-of-care
testing with the Xpert assay and same-day counselling. If they were
virologically suppressed and clinically stable, their care was transferred from
a professional nurse (a nurse with four years of training) to an enrolled nurse
(two years of training).

Those randomised to receive the standard of care had laboratory
viral load testing and care from a professional nurse.

All HIV care followed South African guidelines: clinic
visits every two months, viral load testing at month six, month 12 and then
annually. After one year, stable patients could transfer to the community-based
ART delivery programme.

The 390 study
participants’ mean age was 33 years, 60% were female, a third had been
diagnosed for more than a year and their median CD4 count at enrolment was 468
cells/mm3. Over half lived more than five kilometres from the
clinic.

The study’s
primary outcome was a composite of retention in care and viral suppression
below 200 copies/ml, 12 months after study entry. This was achieved by 89.7%
(175 of 195 participants) in the intervention arm and 75.9% (148 of 195
participants) in the standard-of-care arm. This amounts to an increase of 13.9%
(p = 0.0004). Whereas the study was designed to show the non-inferiority of the
intervention, it actually demonstrated superiority.

Taking the
two components separately, retention in care was increased by 7.7% and
virological suppression by 10.3%. Both these differences were statistically
significant.

While the
laboratory viral load results were usually entered onto the health system
within two days, it took much longer for them to be communicated to the patient – a median of 28 days. A quarter of patients got their results over 54 days
later and 18.5% never received them.

While it
takes around two hours for the Xpert point-of-care results to become available
(improvements in the technology could bring this down), the overall length of
the clinic visits of around two and a half hours was comparable in both arms.
For those in the standard-of-care arm, the wait to have blood drawn was long.

The total
cost for each test (the assay, staff time, consumables) was actually lower for
the point-of-care ($21.53) than the laboratory test ($25.98).

In the
intervention arm, all six patients who had virological failure were switched to
second-line therapy, a median of one day after the test was taken. In the
standard-of care arm, only four of nine patients with virological failure were
switched, after a median of 76 days.

One year
after starting ART, stable patients can transfer into a community-based ART
delivery programme. More patients did so in the intervention arm (60% vs 27%),
and did so much sooner (median 168 days after study entry vs 261 days).

In
qualitative interviews, patients said they liked getting real-time feedback on
their adherence and having problems dealt with quickly:

“It’s a good method because they take bloods
from you and you wait for your viral load results, and you know whether the
treatment works.”

“What is good about POC testing is that you
leave knowing that you need to fix that issue, if there is anything to fix.”

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap

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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends
checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member
of your healthcare team for advice tailored to your situation.